Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program.

Colorectal Cancer Clinical Trial

— CADILLAC  

Official title:

Usefulness of GI-GENIUS in FIT-based Colorectal Cancer Screening Program. Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04673136
• Other study ID #: CADILLAC-01
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: April 2022
• Source: Asociación Española de Gastroenterología
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Deep learning technology has an increasing role in medical image applications and, recently, an artificial intelligence device has been developed and commercialized by Medtronic for identification of polyps during colonoscopy (GI-GENIUS). This kind of computer-aided detection (CADe) devices have demonstrated its ability for improving polyp detection rate (PDR) and the adenoma detection rate (ADR). However, this increase in PDR and ADR is mainly made at the expense of small polyps and non advanced adenomas. Colonoscopies after a positive fecal immunochemical test (FIT) could be the scenario with a higher prevalence of advanced lesions which could be the ideal situation for demonstrating if these CADe systems are able also to increase the detection of advanced lesions and which kind of advanced lesions are these systems able to detect. The CADILLAC study will randomize individuals within the population-based Spanish colorectal cancer screening program to receive a colonoscopy where the endoscopist is assisted by the GI-GENIUS device or to receive a standard colonoscopy. If our results are positive, that could suppose a big step forward for CADe devices, in terms of definitive demonstration of being of help for efectively identify also advanced lesions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3400
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals with a positive result in fecal immunochemical test within the population-based colorectal cancer screening program.
• Complete colonoscopy with cecal intubation.
• Inform consent signed.

Exclusion Criteria:

• Personal history of colorectal cancer.
• Family history of colorectal cancer: =2 FDR or =1 FDR diagnosed before 50 years of age.
• Family history of hereditary colorectal cancer syndromes: Lynch syndrome, FAP, etc.
• Personal history of inflammatory bowel disease.
• Terminal illness.
• Personal history of total proctocolectomy.

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon
• Colonic Polyp
• Colonic Polyps
• Colorectal Cancer
• Colorectal Neoplasms
• Digestive System Neoplasms
• Gastrointestinal Neoplasms
• Intestinal Neoplasms
• Neoplasms
• Polyps
• Serrated Adenoma
• Serrated Polyp

Intervention

Device:
• GI-GENIUS Medtronic
Colonoscopy assisted by GI-GENIUS device

Other:
• Colonoscopy
Standard colonoscopy

Locations

Country	Name	City	State
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital Clinic Barcelona	Barcelona
Spain	Complexo Hospitalario de Ourense	Ourense
Spain	Hospital Universitario Central de Asturias	Oviedo
Spain	Hospital Universitario Río Hortega	Valladolid
Spain	Hospital Universitario Álvaro Cunqueiro	Vigo

Sponsors (2)

Lead Sponsor	Collaborator
Asociación Española de Gastroenterología	Medtronic

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Aziz M, Fatima R, Dong C, Lee-Smith W, Nawras A. The impact of deep convolutional neural network-based artificial intelligence on colonoscopy outcomes: A systematic review with meta-analysis. J Gastroenterol Hepatol. 2020 Oct;35(10):1676-1683. doi: 10.111 — View Citation

Urban G, Tripathi P, Alkayali T, Mittal M, Jalali F, Karnes W, Baldi P. Deep Learning Localizes and Identifies Polyps in Real Time With 96% Accuracy in Screening Colonoscopy. Gastroenterology. 2018 Oct;155(4):1069-1078.e8. doi: 10.1053/j.gastro.2018.06.03 — View Citation

Wang P, Berzin TM, Glissen Brown JR, Bharadwaj S, Becq A, Xiao X, Liu P, Li L, Song Y, Zhang D, Li Y, Xu G, Tu M, Liu X. Real-time automatic detection system increases colonoscopic polyp and adenoma detection rates: a prospective randomised controlled stu — View Citation

Wang P, Liu X, Berzin TM, Glissen Brown JR, Liu P, Zhou C, Lei L, Li L, Guo Z, Lei S, Xiong F, Wang H, Song Y, Pan Y, Zhou G. Effect of a deep-learning computer-aided detection system on adenoma detection during colonoscopy (CADe-DB trial): a double-blind — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of advanced lesions	To determine the impact of the GI-GENIUS device as an assistant to the endoscopist to detect advanced lesions (advanced adenomas and advanced serrated polyps) in FIT-based screening colonoscopies.	15 months
Secondary	Detection of other type of lesions	To determine the ability of the GI-GENIUS device to detect other lesions (colorectal cancer, adenomas, advanced adenomas, serrated polyps, advanced serrated polyps, non-polypoid lesions =10mm and right-sided advanced adenomas)	15 months
Secondary	Characteristics of GI-GENIUS	To describe the characteristics of using the GI-GENIUS device during a colonoscopy: withdrawal time, false-positive and false-negative rate of advanced lesions using the device, etc.	1 month